Safety experts warn healthcare organizations against using PPE made outside the United States or by non-traditional suppliers.
More than half of disposable isolation gowns tested by ECRI failed to meet protection standards and could expose healthcare workers to dangerous viruses, and bloodborne and other pathogens, the safety research organization said.
The alarming results of the test evaluating 34 models of disposable gowns from foreign or non-traditional suppliers prompted ECRI to issue a high-priority hazard alert to warn healthcare organizations about its safety concerns.
"Hospitals have been ramping up their procurement of isolation gowns to protect workers from the novel coronavirus and we're finding that many of the products they are buying simply do not meet basic protection standards," said ECRI President and CEO Marcus Schabacker, MD.
The warnings come as healthcare providers across the nation are scrambling to acquire persona protective equipment during the coronavirus pandemic.
Non-profit, Pennsylvania-based ECRI found that 52% of gowns it tested with unstated levels of protection failed to meet even the Association for the Advancement of Medical Instrumentation's lowest level for protection.
ECRI also tested gowns that claimed AAMI-level protection and found that 50% did not meet the AAMI PB70 standard for liquid barrier performance. In September, ECRI found that 70% of imported Chinese KN95 respiratory masks it tested failed to meet U.S. standards.
"Our research shows that you can't judge the authenticity of the product based on its appearance, labeling, or packaging without product testing," Schabacker said.
If providers have no other options and must use the substandard PPE, ECRI said they should be used only in low-risk patient encounters or first undergo testing for liquid impact and hydrostatic penetration.
"As we have seen first-hand, manufacturer test reports or certificates are not a guarantee that these gowns are safe and effective," said Michael Argentieri, ECRI's vice president for technology and safety. "We are advising our members against purchasing gowns that do not adequately protect healthcare workers, especially during the pandemic."
“Hospitals have been ramping up their procurement of isolation gowns to protect workers from the novel coronavirus and we're finding that many of the products they are buying simply do not meet basic protection standards.”
Marcus Schabacker, MD, President / CEO, ECRI
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.
KEY TAKEAWAYS
ECRI found that 52% of gowns it tested with unstated levels of protection failed to meet even the Association for the Advancement of Medical Instrumentation's lowest level for protection.
ECRI also tested gowns that claimed AAMI-level protection and found that 50% did not meet the AAMI PB70 standard for liquid barrier performance.
In September, ECRI found that 70% of imported Chinese KN95 respiratory masks it tested failed to meet U.S. standards.